In pain therapy strong painkillers and/or opioids have to be administered at times, wherein it is advantageous to administer such painkillers via the nasal mucous membrane for reaching a rapid taking effect. Nasal applicators for such purpose are known in a plurality of forms and may be operated in an easy manner by a patient himself. The discharge mandrel of the nasal applicator is inserted into a nostril and then activated so as to discharge a predetermined dose of the painkiller, e.g., in the sprayed form of an aerosol. A discharge dosage mechanism provided in the interior of the nasal applicator may, e.g., include an engine-driven pump, but is at times, however, also a manually operated transport mechanism that may work, e.g., by pressing together the applicator housing or by pushing a delivery piston.
Nasal applicators are, e.g., known from US 2005/0098583, FR 2 721 521 or GB 2 408 214, wherein the latter GB 2 408 214 includes a delivery prevention mechanism for preventing delivery of a substance when the applicator is not properly fitted. Document FR 2 721 521 discloses a nasal applicator for the nasal application of powder.
While on the one hand, self-administration is useful and desired with painkillers so as to administer the painkiller only when it is in fact needed; on the other hand, the patient self-administering the painkiller has to be protected from an unintentional overdose, in particular if highly effective opioid painkillers are concerned.
Therefore, it has previously been suggested to include in such nasal applicators a locking device that locks the dosage device upon reaching a predetermined discharge amount. For example, the company Aptar offers a nasal applicator with a so-called “lockout” system according to which the dosage device is locked and/or rendered inoperable for a predetermined period of time, as soon as a predetermined number of puffs has been discharged and/or a predetermined number of actuations has been reached.
To date, however, such locking devices are ill-suited and/or not efficiently usable for clinical pain therapy with highly effective opioid painkillers, since with such highly effective medicaments the dose is individually determined by a doctor for a specific individual patient so that a predetermined locking of the applicator is too early for one patient and too late for another and/or also leads to use of a second, not yet locked applicator, if any, for which a new active pharmaceutical substance cartridge is to be opened, so as to administer an additional dose.
On the basis thereof it is the objective of the present disclosure to provide an improved nasal applicator of the abovementioned kind which avoids the disadvantages of the prior art and further develops the latter in an advantageous manner. In particular, a simple and yet safe self-dosing of highly effective painkillers is to be rendered possible which efficiently handles the existing painkiller supplies and still meets an individual patient's needs.
According to the present disclosure, this objective is achieved by a nasal applicator for nasal administration of medicinal active pharmaceutical substances, in particular painkillers, including a dosage device for dosedly discharging the active pharmaceutical substance, dosage determining logic for determining the amount of discharged active pharmaceutical substance as well as a locking device for locking the dosage device when the determined amount of discharged active pharmaceutical substance reaches a predetermined level, characterized in that the locking device is controlled by an electronic control device including a patient data memory into which individual control data of a specific patient can be entered through an input device for individually locking the dosage device for such specific patient. Various alternate embodiments of the present disclosure are laid down in the dependent claims.
The present disclosure suggests to individually control the discharge of active pharmaceutical substance in dependency of a specific patient and to provide therefor an individually programmable control appropriate for a respective user, wherein the relevant control parameters thereof are not yet fixedly preset by the applicator manufacturer but may be entered into the nasal applicator and/or provided for the control thereof in an easy manner by the prescribing doctor and/or his co-workers such as nurses and/or the pharmacist. In accordance with the present disclosure, the locking device for locking the dosage device is controlled by an electronic control device with a patient data memory into which an individual patient's control data may be inputted via an input device for individually locking the dosage device for a specific patient. The locking function of the nasal applicator is thus configurable in dependency of an individual patient, wherein the control device includes a soft, storage programmable logic that may be inputted by the end user and/or the prescribing doctor. Advantageously, the patient data memory is in this connection a repeatedly overwritable, in particular non-volatile read only memory, e.g., in the form of an EPROM, so that the relevant control data such as admissible maximum dose or unlocking code are easily programmable, but remain stored when the apparatus is turned off. Due to the individually adjustable control data the nasal applicator may be configured such that it is suitable for disparate patients, different anamneses and diverging pathologic diagnostic findings, respectively.
In particular, the nasal applicator may be individually configured with regard to the dischargeable maximum amount of active pharmaceutical substance, wherein on the one hand a maximum amount per time, e.g., in the form of microgram/hour, and/or on the other hand also absolute maximum amounts, e.g., with active pharmaceutical substances that are difficult to metabolize, may be predetermined, upon reaching of which maximum amounts the locking device is respectively activated, so that the dosage device may only discharge the respective individually predetermined maximum amount of active pharmaceutical substance. Such admissible active substance maximum amounts may be variably predetermined by inputting the appropriate control data into said patient data memory. In a further development of the present disclosure, the application amounts and/or application maximum amounts that are discharged by the discharge means may for example be controlled in dependency of the patient's weight or his opioid habits.
In this connection, the individual configuration for a specific patient may basically be effected in different ways. In order to achieve an easy inputting of control data into the nasal applicator, the nasal applicator and/or the control device thereof and/or the patient data memory thereof may, in an advantageous further development of the present disclosure, be connected via a data communication interface to a superordinated, external computer, from which all necessary control data for a respective patient and/or user may be inputted. Such external computer may in this connection basically be an off-the-shelf PC onto which a control configuration software adapted to the nasal applicator is installed which software is able to communicate with the control device of the nasal applicator and/or to store the necessary data in the patient data memory thereof. In particular, the nasal applicator may be connected via said data communication interface to a hospital ward computer or a pharmacy or drugstore computer, from which the control functions of the nasal applicator are individually adapted to the intended user, in particular the abovementioned admissible maximum dose, or also other control functions to be adapted individually. Accordingly, the external computer may be an input device to the nasal applicator.
The data interface may basically be adapted in different ways, e.g., in the form of a USB interface, wherein the external computer and/or the control device of the nasal applicator optionally has self-recognition means or self-adaption means, e.g., in the form of an appropriate software module stored in memory of the control device so that upon plugging in of the nasal applicator and/or the connection of the said data communication interface, a self-recognition of the plugged-in apparatus is effected and a configuration according to the plug-and-play principle is possible.
Alternatively or in addition to the configurability via an external data communication interface, the nasal applicator itself may have an appropriate input device rendering it possible to input a patient's individual control data into the control device and/or the patient data memory thereof. The input device at the nasal applicator itself may be advantageously adapted such that it is sufficiently small, e.g., in the form of a keyboard as it is for example known from mobile phones. Advantageously, also a touch screen may be provided as an input device at the nasal applicator, either directly at the housing or in attachable form for example similar to an external PC keyboard connectable to the nasal applicator, if necessary even in wireless manner connectable, wherein in this case the control device of the nasal applicator may contain the necessary functional modules in terms of control technology in order to transform the keyboard entries into appropriate signals. Accordingly, the input device may be a manually operable input device.
In order to simplify the use, the nasal applicator may—for example in the form of the aforesaid touch screen—include a display device for displaying input prompts and already inputted input values by means of which a communication menu and/or a menu control may be provided, which renders it easier for the user to input data and/or directs and instructs him when doing so.
Such an input device at the nasal applicator itself and/or input device attachable thereto may advantageously also be used to keep records of the patient's discomfort. By means of a suitable input element, for example in the form of the aforementioned touch screen, the patient may input discomfort data, which may include one or more of the level of discomfort, the duration of discomfort and/or the frequency of discomfort at the nasal applicator when discomfort occurs. In the easiest case simply the occurrence of a pain pulse may be documented, e.g., by pressing a pain button so that then the frequency of occurrence may be determined and conclusions may be drawn on the basis thereof regarding the applicable dose. Alternatively or in addition in a further development, also the duration of a phase of discomfort may be determined, for example by inputting the beginning and the end, and/or the level of discomfort may be determined, for example by inputting values on a predetermined scale of discomfort level or by pressing the input device several times.
The inputted data regarding level, duration and/or frequency of discomfort may be stored in a storage means directly at the nasal applicator and/or be communicated via a suitable data interface to an external memory so that the stored data may subsequently be evaluated by a doctor or also with the aid of a computer. Alternatively or in addition to such storing of said data, the inputted level, duration and/or frequency of discomfort may also be evaluated by a control module to the effect that a change in the dose and/or the locking of the nasal applicator is aimed at or an adjustment of other functions of the nasal applicator is aimed at by modifying and/or adapting a specific patient's individual control data. For example, dosage algorithms may be adapted, e.g., such that in the case of mixtures of active pharmaceutical substances the mixing ratio is altered and/or the delivered amounts of active substances are altered.
Alternatively or in addition to the aforementioned configuration options, the nasal applicator and/or the control device thereof may also be individually configured for a specific patient by inserting into the nasal applicator at least a part of the control device thereof and/or the patient data memory thereof together with an optionally replaceable active substance cartridge and/or an active substance receptacle the adaption of which is irrelevant. In an advantageous further development of the present disclosure the nasal applicator may include a replaceable active substance receptacle for example in the form of an active substance cartridge or an active substance container, at which active substance receptacle a writable patient data memory may be provided so that for example still in a hospital pharmacy, when providing the pharmaceuticals and/or the active substance for a specific patient, the application stated for example on the prescription, for example including the admissible maximum dose, may be inputted into the patient data memory at the active substance container. For this the aforementioned external memory for example in the form of a hospital ward computer may be equipped with a write/read piece of equipment through which a specific patient's individual control data may be programmed and/or stored in a memory chip fixed to the active substance receptacle. If the active substance receptacle is inserted into the nasal applicator, the chip communicates with the control device and the control data stored in the memory of the chip attached to the receptacle are imported and form the basis for the control of the nasal applicator.
The memory attachable to the active substance receptacle may in this connection basically be adapted in a plurality of forms, for example in the form of a memory chip, if necessary also in other forms such as for example a bar code that is applied to an adhesive label gluable to the active substance receptacle. For example, a code such as a bar code may comprise the input device described herein and may thus store individual control data for a specific patient.
In a further embodiment of the present disclosure, the chip attachable to the active substance receptacle, into which chip a specific patient's individual control data are storable, may also include a part of the control device for the nasal applicator, for example for controlling the locking device thereof, so that not only control data may be read out from the receptacle-sided memory chip, but also control commands may be given by it upon insertion of the active substance receptacle into the nasal applicator.
In the alternative or in addition to such configurability by means of insertion of the active substance receptacle, the nasal applicator and/or the control device thereof may include a wireless signal receiver for receiving a specific patient's individual control data and/or may cooperate with a transmitter that the patient and/or user of the nasal applicator wears on his body or keeps in his direct proximity. By means of such cooperation with such external transmitter the use of the nasal applicator may be significantly improved in particular with regard to safety and misuse, since the necessary control data controlling, in particular unlocking the nasal applicator are available only when or if the “right” patient and/or user is using the nasal applicator.
The aforementioned external transmitter and/or the therewith communicating signal receiver at the nasal applicator may basically be adapted in different ways, wherein advantageously the aforementioned transmitter includes at least part of the aforementioned patient data memory and/or is connected thereto, so that the aforementioned external transmitter has access to the relevant individual control data of a specific patient and may transmit and/or provide these to the control device of the nasal applicator via the signal receiver on the applicator. As an alternative to wireless transmission, in some examples the transmission may be effected by connecting an appropriate signal line.
In a further advantageous embodiment of the present disclosure, the said external transmitter that the patient and/or user may wear on his body may include an RFID element, thus a control element communicating in radio frequency range, in which control element a patient's individual control data are stored which data may be received by an RFID reader and/or sending means at the nasal applicator. Thus, the RFID element constitute the input device in some examples. In the alternative or in addition to such transmission of a patient's individual control data by means of RFID technology, data transmission could, if necessary, also be effected in another suitable format, for example according to the bluetooth standard, wherein, however, use of an RFID element as external data memory wearable on the body is particularly favorable as far as power supply and lack of radiation in its inactive mode are concerned.
The said RFID element may advantageously be fixed directly to the body of the user, for example by means of a wristband or a leg strap, a necklace or another suitable body fastener, but may also be positioned in another manner in proximity of the body, if necessary, for example when used in a hospital by fixing it to the patient's bed.
By means of such external transmitter in particular in the form of the said RFID element, particularly a functional lock and/or an unlocking function may be implemented at the nasal applicator, in particular in such manner that the nasal applicator is only usable and/or operable, if the said transmitter is positioned sufficiently close to the nasal applicator. The basic locking of the nasal applicator and the unlocking in dependency of a specific user's individual code coming along therewith brings about particular advantages, if the locking function also takes into account maximum amounts of the discharged active pharmaceutical substance in the manner described; however, independently thereof it also represents an advantageous embodiment and an independent aspect of the present disclosure.
The nasal applicator and/or the control device thereof may in a further development of the present disclosure be provided with a user identification means such as a user identification device for automatically identifying the user of the nasal applicator and an unlocking device and/or unlocking means such as unlocking logic for unlocking the locking device in dependency of a respective determined user of the nasal applicator. The said user identification device may in this connection basically be adapted in different ways; it may, e.g., include a body feature sensor such as a fingerprint sensor, however, in the alternative or in addition it advantageously has a code receiver for receiving a specific patient's individual code and comparing such received code with a predetermined code. Accordingly, the nasal applicator may be unlocked by inputting and/or importing a code, whereas it may be locked when the correct code is not inputted and/or imported.
In an advantageous further development of the present disclosure, the said individual code of a specific patient may be stored in the aforementioned external memory element in particular in the form of the RFID element, so that the nasal applicator is only unlocked if said RFID element and/or external memory element is kept ready.
In a further development of the present disclosure, the applicator-sided RFID transmitter and/or receiver or—in the alternative or in addition—the RFID element may, in terms of communication range, in particular receiver sensitivity and/or transmitter power, be adapted such that the control data from the RFID element are transmitted only at a distance between the RFID element and the RFID transmitter and/or receiver of less than for a predetermined distance, for example 2 m, and optionally less than 1 m.
In order to be able to easily configure and/or use the nasal applicator for a plurality of active pharmaceutical substances, in particular a plurality of painkillers, the control device of the nasal applicator and/or the storage means thereof may in an advantageous further embodiment of the present disclosure include a plurality of preconfiguration datasets for preconfiguring the control of the locking device and/or the dosage device for a plurality of active pharmaceutical ingredients, from which preconfiguration datasets an appropriate preconfigured dataset is then selectable in dependency of a respective used active pharmaceutical substance. Such selection may be effected via the aforementioned input device, but also, as the case may be, by importing the respective preconfiguration data from the aforementioned external computer, wherein in such case the preconfiguration datasets are provided at the external computer.
In order to simplify the selection of the preconfiguration datasets, the control device of the nasal applicator may include an active pharmaceutical substance identification module which automatically identifies the respective used active pharmaceutical substance and selects the appropriate preconfiguration data. To this purpose an appropriate, importable code may be attached to the active pharmaceutical substance container to be inserted, for example in the chip element fixed to the active substance container or a bar code applied thereto. The active pharmaceutical substance identification module at the nasal applicator includes suitable code detection means such as code detection logic, in order to import and/or detect the code provided at the active pharmaceutical substance container and to select the correct preconfiguration data in dependency of the imported and/or detected code. Such preconfiguration may for example comprise predetermining an absolute maximum amount irrespective of the patient in order to reduce the possible error sources when programming for an individual patient. Alternatively or in addition, said preconfiguration data may include standard control data for a standard administration of the active pharmaceutical substance which may then either be adopted by individually programming for a specific patient or may be altered in the desired way so that only the data in fact deviating from the standard routine are to be inputted.
In order to facilitate self-administration of the active pharmaceutical substance for weaker patients or patients affected by pain therapy they already had, and/or in order to simplify use of the nasal applicator, the nasal applicator may in a further development of the present disclosure include an energy-driven transport actuator which is responsible for or at least supports the transportation and discharging of the active pharmaceutical substance by means of external energy, wherein said transport actuator may work electrically, magnetically, pneumatically or hydraulically or by means of other kinds of energy. In particular, the transport actuator may be provided in the form of a pressure accumulator and/or a spring accumulator, in order to drive a suitable active substance transporting element such as for example a pump or a piston, by means of the stored energy. Accordingly, the user merely has to effect activation of the transport actuator and/or the transport element driven thereby. Hereby, the user is spared from having to press together the nasal applicator and/or from having to push a delivery piston, for example.
If the nasal applicator works in the above described way with a power-driven transport actuator, said locking device may in an easy manner lock the transport actuator and/or render it inactive, for example by interrupting the energy supply or by locking the pressure or spring accumulator. Alternatively or in addition, also a mechanical locking of, for example, the dosage device or the transport element thereof may be provided, for example by engaging a locking latch or similar elements, which also may advantageously be effected by means of external energy.
In advantageous further development of the present disclosure the nasal applicator is provided with a determining and/or detection device which determines and/or detects prior to and/or at the time of discharge of the active pharmaceutical substance whether the nasal applicator is positioned in and/or at the nose, in particular whether the discharge mandrel is positioned inside a nostril, or whether in general the discharged active pharmaceutical substance is in fact applied into the nose. The determining device may basically be adapted in different ways, wherein an advantageous further development may consist in the determining device including a body temperature sensor or generally heat detection means for detecting body heat. If the determining device determines a temperature in the range of body temperature at the nasal applicator, in particular at the discharge mandrel thereof, it may be assumed that the nasal applicator applies the active pharmaceutical substance not just into the environment, but in fact into the nose.
In particular, said determining device may have bi-metal elements at the discharge mandrel and/or infrared elements at or in the region of the discharge mandrel, by means of which positioning of the discharge mandrel at the nose and/or into a nostril may be detected.
The determination of the position of the nasal applicator when discharging the active pharmaceutical substance may be used for a plurality of control functions. In an advantageous further development of the present disclosure the locking device of the nasal applicator may be drivable by said determining device, in particular such that the locking device is only unlocked if the nasal applicator is positioned in and/or at the nose. Hereby it may be avoided that valuable active substance is wasted and/or discharged into the environment.
In the alternative or in addition, data such as a signal from said determining device may be input to the dosage determining logic. In particular, when determining the administered dose, the dosage determining logic may take into account data from the determining device such as whether the nasal applicator is in fact positioned in and/or at a nose at the time of discharge of the active pharmaceutical substance. Discharged active pharmaceutical substance may for example only be considered as administered dose if the determining device determines that the discharge mandrel was correctly positioned inside a nostril.
In the following, the present disclosure is described in more detail on the basis of one exemplary embodiment and related drawings.